HPV Self-sampling to Improve Access to Cervical Cancer Screening for Persons With HIV and/or Underserved Individuals

Last updated: September 2, 2022
Sponsor: University of Washington
Overall Status: Active - Enrolling

Phase

N/A

Condition

Cervical Cancer

Vaginal Cancer

Uterine Disorders

Treatment

N/A

Clinical Study ID

NCT05528237
STUDY00014442
5KL2TR002317-05
  • Ages > 25
  • Female
  • Accepts Healthy Volunteers

Study Summary

The objective of this study is to evaluate self-collection of vaginal samples for HPV testing as an alternative cervical cancer screening strategy for persons with HIV and/or limited access to care. Self-collection kits will be offered to persons who refuse a Pap smear or are overdue (>=6 months) for cervical cancer screening, with screening uptake recorded as a primary outcome. Kits will be offered in-clinic to individuals who refuse a Pap smear, and individuals overdue for screening will have the option to receive and return kits in the mail. The investigators will additionally administer a phone-based survey to evaluate knowledge about HPV and cervical cancer, barriers and facilitators to screening, and attitudes towards screening. Data from medical records will be abstracted to describe the clinical characteristics of the sample and measure receipt of follow-up procedures. Focus groups will be conducted with clinic administrators, staff, and HIV and women's health experts to evaluate clinic and provider barriers and facilitators to cervical cancer screening. The investigators hypothesize that HPV self-sampling will result in favorable patient-centered outcomes and could reduce disparities in access to screening.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age >=25 and <65 (individuals without diagnosed HIV) or >=30 years (individuals withdiagnosed HIV)
  • Female sex at birth
  • Proficient in English or Spanish
  • Refused a Pap smear or are >=6 months overdue for cervical cancer screening

Exclusion

Exclusion Criteria:

  • Current pregnancy
  • Complete hysterectomy
  • History of cervical cancer
  • Unable to provide informed consent

Study Design

Total Participants: 50
Study Start date:
August 18, 2022
Estimated Completion Date:
October 07, 2022

Connect with a study center

  • MAX Clinic

    Seattle, Washington 98104
    United States

    Site Not Available

  • Madison Clinic

    Seattle, Washington 98104
    United States

    Site Not Available

  • SHE Clinic

    Seattle, Washington 98103
    United States

    Site Not Available

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